On April 15, 2022, the Beijing Intellectual Property Court publicly pronounced a first-instance judgment on a dispute between the plaintiff Chugai Pharmaceutical Co., Ltd. and the defendant Wenzhou Haihe Pharmaceutical Co., Ltd. over whether Haihe’s drug falls into the protection scope of Chugai’s patent. After trial, the Court held that Haihe’s generic drug does not fall into the protection scope of the patent at issue and ruled to reject the plaintiff’s litigation claims.

This case is the first drug patent linkage lawsuit in China since the newly amended Patent Law came into force.

Case Brief:

The plaintiff is the patentee of the Chinese patent no. 200580009877.6, titled ED-71 preparation (the patent at issue), and is also the marketing authorization holder of the relevant marketed patent drug “Eldecalcitol Soft Capsules”, which is mainly used for treating osteoporosis. The plaintiff registered the above-mentioned drug and the patent at issue on the Chinese Marketed Drug Patent Information Record Platform. The plaintiff found that the defendant filed an application with the state food and drug administration authorities for the marketing authorization of a generic drug named “Eldecalcitol Soft Capsules”, and also made a Category 4.2 statement on the Chinese Marketed Drug Patent Information Record Platform on the above-mentioned generic drug, stating that its generic drug did not fall within the protection scope of relevant patent right.

Therefore, the plaintiff filed a lawsuit with the Beijing Intellectual Property Court pursuant to Article 76 of the newly amended Patent Law, requesting confirmation on whether the generic drug “Eldecalcitol Soft Capsules” for which an application for registration was filed by the defendant fell within the protection scope of the patent at issue.

After trial, the Beijing Intellectual Property Court held that the technical scheme used by the defendant’s generic drug was neither the same as nor equivalent to the technical scheme of claim 1 of the patent at issue, so the technical solution did not fall within the protection scope of claim 1 of the patent at issue; since claims 2-6 are dependent claims of claim 1, where the technical scheme of the defendant’s generic drug did not fall within the protection scope of claim 1, it also did not fall within the protection scope of claims 2-6. Therefore, the plaintiff’s claim that the defendant’s generic drug falls within the protection scope of claims 1-6 of the patent at issue was not tenable, and thus the court dismissed the case.

The plaintiff expressed in court that they would file an appeal, while the defendant expressed that they accepted the first-instance judgement.

Judge’s Comments:

We know that if pharmaceutical companies do not make a profit by selling drugs, they will lack the motivation for research and development, then no new drug will be developed and people will not have no good drugs. However, if the price of new drugs is too high, people will not afford to use them when they get sick; instead, high-quality generic drugs which have low R&D costs and thus have low prices are often affordable for people. Therefore, it is necessary to balance the interests of original drug developers and generic drug enterprises, so that people can have good and cheap drugs. The "drug patent linkage system" is precisely a "legal prescription" given by the Patent Law to solve the above problems.

On June 1, 2021, the newly amended Patent Law came into force, in which a new Article 76 was added to provide a resolution mechanism for disputes over patents relating to drugs for which applications for registration are filed, thereby officially establishing China’s drug patent linkage system. Later, China’s SPC released the Provisions on Several Issues concerning the Application of Law in the Trial of Civil Cases involving Patent Disputes Related to Drugs for Which Applications for Registration are Filed, which provided detailed stipulations on the dispute resolution mechanism and determined that lawsuits relating to drug patent linkage are subject to the jurisdiction of Beijing Intellectual Property Court.

The Judge in charge of the above case expressed that the significance of drug patent linkage system is not only to enhance original drug developers’ judgment of the certainty of drug market, encourage their continuous investment (in R&D of new drugs) and promote the innovation and development of the industry, but also to confirm the marketing risk of generic drugs in advance for generic drug enterprises, avoid the rush marketing of generic drugs and the high amount of possible litigation compensation caused thereby, and thus promote the high-quality development of generic drugs. By balancing the interests of original drug developers and generic drug enterprises, the accessibility of drugs are maximized, so as to allow the Chinese people to have good and cheap drugs.

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